A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

NCT05507346 | Completed FDA Device

• 1 other identifier: KCT 009 (TEAYS)
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

Conditions

Lymphedema; Venous Insufficiency; Lymphedema, Lower Limb; Chronic Venous Insufficiency; Lymphedema of Leg

Outcome Measures

Primary Outcomes (3)

• Limb volume reduction or maintenance

  Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle at 4cm increments to the waist region. Measurements to be taken for both lowerr extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 3

  3 months

• LYMQOL

  The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 3

  3 months

• Therapy adherence tracking

  A table will be provided to patient to document days of use with the device to track adherence

  3 months

Secondary Outcomes (2)

• Safety/AEs

  3 months

• Patient survey on preference

  3 months

Study Arms (2)

Dayspring, Non-Pneumatic Active Compression Device (NPCD)

EXPERIMENTAL

The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.

Device: Cross over Device (PCD or Dayspring - alternate to first group)

Advanced Pneumatic Compression Device (APCD)

ACTIVE COMPARATOR

A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.

Device: Cross over Device (PCD or Dayspring - alternate to first group)

Interventions

Cross over Device (PCD or Dayspring - alternate to first group) DEVICE

Cross over after three month of use and a month of washout period

Advanced Pneumatic Compression Device (APCD); Dayspring, Non-Pneumatic Active Compression Device (NPCD)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age
• Capable and willing to sign the informed consent and deemed capable of following the study protocol
• Subjects must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency

You may not qualify if:

• Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
• Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
• Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
• Individuals who present with Ankle-brachial Index (ABI) screening score \< 0.8 and \> 1.30, indicating the possibility of Peripheral Arterial disease (PAD)
• Diagnosis of lipedema
• Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• Diagnosis of acute infection (in the last four weeks)
• Diagnosis of acute thrombophlebitis (in last 6 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled/uncompensated)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Subjects with poorly controlled asthma

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (1)

Stanley G Rockson

Oakland, California, 94607, United States

Location

Related Publications (1)

• Berland T, Barfield M, Winokur R, Davis S, Ralph V, Chatham N, Rockson S, Maldonado TS. Use of a Portable, Non-pneumatic Active Compression Device in treatment of Phlebolymphedema: a TEAYS sub-analysis. Ann Vasc Surg. 2026 Mar 16:S0890-5096(26)00133-0. doi: 10.1016/j.avsg.2026.02.039. Online ahead of print.

  PMID: 41850352 DERIVED

MeSH Terms

Conditions

Lymphedema; Venous Insufficiency

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: September 6, 2022
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: December 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)